Reported Sep 2, 2026 · Ongoing · Updated Sep 16, 2026
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes
Henry Schein Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Henry Schein Inc. · 41 Weaver Rd · Denver, PA · 17517-9308
Is this the product you have?
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes
4 of 4 products
| Model / number | Product as published |
|---|---|
1840 | 949-3594, Mfr ; Lots 2529604, 2538147, 2608145 |
1841 | 949-3595, Mfr ; Lots 2539075, 2539313, 2609789, 2539065 |
1842 | 949-3596, Mfr ; Lots 2536632, 2609174, 2610099 |
1843 | 949-3597, Mfr ; Lots 2535296, 2537418, 2607283 is a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures. |
- Amount recalled
- 853 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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